Method And Device For The Treatment Of Obstructive Sleep Apnea And Snoring

ABSTRACT

The device relates to methods and devices for the treatment of obstructive sleep apnea syndrome.

CROSS REFERENCE RELATED APPLICATION

This patent claims priority to provisional patent No. 60/547,897 filedFeb. 26, 2004. All references are incorporated in entirety.

FIELD OF THE INVENTION

The invention relates to methods and devices for the treatment ofobstructive sleep apnea syndrome by retraction of soft tissue in theoral cavity and pharynx. The invention also relates to devices implantedwithin the tongue that are used for diagnosis and treatment of medicaldisorders.

BACKGROUND

Snoring, upper airway resistance syndrome, and obstructive sleep apneasyndrome (OSAS) are all breathing disorders related to narrowing of theupper airway during sleep. Approximately 18 million Americans have sleepdisordered breathing, but fewer than 50% are presently being diagnosed.More than 50% of Americans over age 65 have sleep difficulties, andprevalence of sleep problems will therefore increase as the over-65population increases. Each year, sleep disorders, sleep deprivation, andexcessive daytime sleepiness add approximately $16 billion annually tothe cost of health care in the U.S., and result in $50 billion annuallyin lost productivity.

Pathophysiology of Sleep Disorders

Sleep disorders are largely caused by too much soft tissue in thethroat. Humans are unique because their upper airway has a curved shape,an anatomical change that is related to the evolution of human speech.As a result the upper airway of humans is more flexible than otherspecies and is more prone to collapse under negative pressure. In theawake state a certain amount of tone is present in upper airway musclesto prevent this collapse. However, during sleep muscle tone decreases inupper airway muscles and in certain susceptible individuals thisrelaxation allows the airway to collapse (Horner R L. Motor control ofthe pharyngeal musculature and implications for the pathogenesis ofobstructive sleep apnea. Sleep 1996; 19: 827-853). The upper airwayrefers to the air filled spaces between the nose and the larynx (FIG.1). The most relevant part of the upper airway for sleep disorders isthe air cavity called the pharynx. The pharynx can be divided into threeanatomical levels (FIG. 2):

1) The nasopharynx is the part of the pharynx in the back of the nasalcavity.2) The velopharynx corresponds to that part of the pharynx containingthe velum (soft palate) and tongue curve.3) The hypopharynyx is behind the tongue base.

The velopharynx is more susceptible to collapse because there are moresoft tissue structures, leaving less room for airflow. The majorstructures of the velopharynx are the soft palate and the tongue, bothof which are very flexible. The soft palate acts as a barrier betweenthe mouth and the nose. In many people it is longer than necessary andextends down between the tongue and pharyngeal wall. The tongue is thelargest muscular organ of the upper airway and is anatomically dividedinto a blade, body and base (FIG. 3). Most of the tongue's curve is atthe junction of the tongue body and base.

In the awake condition the structures of the velopharynx maintain theirshape because of continuous tone of their internal muscles. When thistone decreases, such as during sleep, these structures become quiteflexible and distensible. Without the normal muscle tone that keeps themis place, they tend to collapse at relatively low negative pressures.Although muscles relax throughout the body during sleep many of therespiratory muscles remain active. Specifically, the major muscle thatpulls the tongue forward, the genioglossus muscle, has been reported toshow decreased activity during sleep, although it is active duringobstructive apneas. Normally the genioglossus is capable of moving thetongue forward and even projecting it out of the mouth. Why thegenioglossus muscle fails to prevent obstructions has not beenexplained.

During inspiration the chest wall expands and causes negative pressureto draw air into the nose and mouth and past the pharynx into the lungs.This negative pressure causes upper airway soft tissue to deform,further narrowing the airway. If the airway narrows enough the air flowbecomes turbulent causing the soft palate to vibrate. The vibration ofthe soft palate produces the sound known as snoring. Snoring isextremely common effecting up to 50% of men and 25% of women. By itselfsnoring is not a medical problem although it can be a tremendous problemfor the snorer's bed partner and a major cause of marital strain.

A small amount of decreased airflow or brief obstructions occurs in allhumans during sleep. These episodes are counted as medically significantif airflow is decreased more than 50% of normal (hypopnea) or if airflowis obstructed for more then 10 seconds (apnea). The number of apneas andhypopneas that occur during each hour of sleep is measured to diagnosethe severity of the sleep disorder. These episodes of hypopnea or apneaoften cause some degree of arousal during sleep. Although the patientdoes not awaken to full consciousness, the sleep pattern is disturbedcausing the patient to feel sleepy during the day. If the frequency ofhypopnea or apnea is more than 5 episodes an hour it is called upperairway resistance syndrome. These patients often show symptoms relatedto the sleep disruption. Specifically, these patients are excessivelysleepy during the day. In addition more subtle symptoms such asdepression and difficulty concentrating are also common.

Technically the diagnosis of OSAS is defined as an average of more than10 episodes of hypopnea or apnea during each hour of sleep. Although theairway is obstructed the patient makes repeated and progressively moreforceful attempts at inspiration. These episodes are largely silent andcharacterized by movements of the abdomen and chest wall as the patientstrains to bring air into the lungs. Episodes of apnea can last a minuteor more, and during this time the oxygen levels in the blood decrease.Finally, either the obstruction is overcome, usually producing a loudsnore, or the patient awakes with the feeling of choking.

Very common symptoms in OSAS patients are morning headaches and acidreflux. During airway obstructions the forceful attempts to inspire aircan cause tremendous negative pressure in the chest. These high negativepressures can draw acid up the esophagus from the stomach. The acid cantravel all the way into the mouth and cause inflammation of the vocalcords and nasal mucosa. The presence of the acid in the upper airwaycauses reflex bronchoconstriction in the lung that is similar to anasthma attack. If even a small amount of acid enters the lung it cancause the vocal folds to close tightly and itself cause a prolongedapnea called laryngospasm. In many patients the repeated stretching ofthe espophageal sphincter causes chronic changes and these patients canhave acid reflux during the day.

Most importantly, sleep disorders can cause serious medical problems anddeath. Apneas cause a large strain on the heart and lungs. Over timerepeated episodes of apnea cause chronic changes leading tohypertension. Long periods of apnea allow the oxygen levels in the bloodto decrease. In turn the low oxygen can cause heart attacks or strokes.

Treatment of Sleep Disorders

Although OSAS occurs in both children and adults the cause and treatmentare very different. OSAS in children almost always occurs when the childhas large tonsils, and tonsillectomy cures the condition. Tonsilsnaturally decrease in size with age and are rarely a problem in adults.Instead susceptible adults usually have enlargement of their tongues,soft palate and/or pharyngeal walls. This enlargement is mostly due tofat deposits within these structures.

Adult sleep disorders are difficult to treat for a variety of reasons.The upper airway is a very mobile structure that performs the criticalfunctions of swallowing and speech. These functions are easilycompromised by surgical procedures or other interventions. In addition,the upper airway also has a large amount of sensory innervation thatcauses reflexes such as gagging and coughing. Theoretically a physicalstent that is placed in the oral cavity and pharynx would be completelyeffective in relieving sleep apnea. When a patient is totallyunconscious, such as when they are anesthetized for surgery, the airwaycan be stented open by placing a curved oral tube into the mouth andpharynx. In addition, endotracheal tubes establish a secure airway forartificial ventilation. However, after anesthesia wears off, patientsimmediately sense and react to the foreign objects in their throats andexpel them. Therefore devices such as oral and endotracheal tubes, oranything similar, cannot be used for the treatment of OSAS.

Although physical stents cannot be used for OSAS an indirect way ofstenting the upper airway with positive air pressure is the mostcommonly prescribed treatment for OSAS. This method is called continuouspositive airway pressure (CPAP). CPAP requires the use of a mask tightlyattached around the nose and connected to a respirator. The exact amountof positive pressure is different for each patient and must be set byovernight testing using multiple pressures. The positive pressure actslike a stent to keep the airway open. CPAP is not a cure but a therapythat must be used every night. Although many OSAS patients are helped byCPAP it is not comfortable for the patient or their bed partner.Patients often cannot tolerate the claustrophobic feeling of a masktightly attached to their face. In addition there are often manytechnical problems with maintaining a proper seal of the mask to theface. For these reasons up to half of all patients who are prescribedCPAP stop using it within 6 months (Sanders, “Medical Therapy for SleepApnea,” Principles and Practice of Sleep Medicine, 2nd Edition, pp.678-684).

Tracheotomy

The only completely effective surgical therapy for OSAS is to bypass theentire upper airway by performing a permanent tracheotomy, a surgicalprocedure that forms a direct connection to the trachea through theneck. This is a dangerous procedure reserved for the worst cases whenthere is a high risk of serious medical complications from OSAS.Notably, temporary tracheotomies are often performed on patients withsevere OSAS to control the airway before performing before any otherprocedure is performed on their upper airway. The reason is that thesepatients are at high risk of acute airway obstruction and death if thereis any swelling in their airways. Due to the tremendous excess ofswollen tissue in their upper airways OSAS patients are very difficultto intubate under emergency conditions. Similarly there is tremendousamount of fat in the neck that makes emergency tracheotomies extremelyhazardous.

Prior to current conservative measures, postoperative deaths were notuncommon in severe OSAS patients. Moreover these patients often haveacclimated to breathing against resistance, and when the resistance issuddenly removed their respiratory drive decreases. Even today thestandard of care in treating most OSAS patients is to have them underclose observation in an intensive care unit or recovery room aftersurgical procedures.

Soft Palate Procedures for Snoring

As the soft palate vibrates more than other tissues it plays adisproportional role in snoring. Various surgical therapies areavailable that shrink or stiffen the soft palate. The main procedureused is called uvulopalatopharyngoplasty [UPPP]. UPPP excises excesssoft tissue of the pharyngeal walls and soft palate with a surgicalscalpel. Because so much mucosa of the pharyngeal area is traumatizedduring a UPPP there is a large amount of post operative swelling andsevere pain. In selected patients who snore but have no obstructionsmore limited versions of the UPPP can be done with lasers or electricalcautery.

Newer procedures minimize trauma to the mucosa and use needles to reachthe underlying soft tissue to shrink its volume or stiffen it so that itresists vibration. Electrodes can be inserted into the soft palate todeliver radiofrequency energy that shrinks or stiffens the palate(Powell, N B, et al (1998) Radiofrequency volumetric tissue reduction ofthe palate in subjects with sleep-disordered breathing. Chest 113,1163-1174.) (Somnoplasty; Somus; Mountainview, Calif.). Mild causticagents can be injected that decrease the volume of the soft palate. U.S.Pat. No. 6,439,238 to Benzel teaches the application of a stiffeningagent to the surface of the soft palate. Most recently, office basedimplantation of plastic inserts to stiffen the soft palate has beenapproved by the FDA (Pillar® Procedure, U.S. Pat. No. 6,546,936: Methodand apparatus to treat conditions of the naso-pharyngeal area).

The fundamental shortcoming of all procedures that target the softpalate, including the newer techniques, is that they only partiallyimprove OSAS (Loube DI (1999) Technologic Advances in the Treatment ofObstructive Sleep Apnea Syndrome. Chest. 1999; 116:1426-1433, Doghramji,K, et al (1995) Predictors of outcome for uvulopalatopharyngoplasty.Laryngoscope 105, 311-314). Although studies report a decrease in thenumber of apneas these patients are rarely cured. Evidently the criticalstructure causing OSAS is not the soft palate but the tongue.

Tongue Base Procedures for OSAS

The methods used to treat the tongue base in OSAS are either topermanently decrease its volume, to decrease its flexibility or to movethe entire tongue forward.

Surgical excision of the tongue base has been poorly effective. Theresults for scalpel or laser resection of the tongue base in OSAStreatment have not been good enough to recommend continued applicationof these procedures (Mickelson, S A, Rosenthal, L (1997) Midlineglossectomy and epiglottidectomy for obstructive sleep apnea syndrome.Laryngoscope 107, 614-619). More recently radiofrequency (U.S. Pat. No.5,843,021 to Edwards) and ultrasonic (U.S. Pat. No. 6,409,720) energyhave been proposed to shrink and stiffen the tongue base. The energy isdelivered via needle electrodes that are inserted into the tongue baseto cause a lesion that scars and shrinks over time. To avoidpostoperative swelling and pain a limited amount of lesioning is done ina single session and patients require an average of 5 treatments. Abouta third of patients have greater than 50% improvement in their OSAS.However, approximately a fourth of patients have significant postoperative complications, including tongue base ulcerations andabscesses, and temporary tracheotomy.

A recent introduced device for tongue base advancement is the Repose®system (Influent Corp; San Francisco, Calif.). The Repose® procedure isperformed under general anesthesia, and a screw is inserted at the baseof the mandible. The screw contains attachments for a permanent suturethat is tunneled under the mucosa of the floor of the mouth to the backof the tongue, then passed across the width of the tongue base, andbrought back to attach to a metal hook screwed into the bone of themandible. The suture is tightened to displace the tongue base forward,and caution must be observed to prevent excess tension leading tonecrosis of tissue. Unfortunately studies of the Repose® procedure showthat it is ineffective at eliminating OSAS. Only 1 of 15 patients wascured of OSAS while 2 patients had to have the suture removed due topain and swelling.

More aggressive surgical procedures require reconstruction of themandible, facial, skeleton or the hyoid bone. An example of the art isU.S. Pat. No. 6,161,541 to Woodson that teaches a method of surgicallyexpanding the pharyngeal airway. These procedures require extensivesurgery with higher risks and much longer recovery periods.

Other proposed methods for treating the tongue base include stiffeningthe soft tissue by injection of sclerosing particles U.S. Pat. No.6,742,524 (Method and apparatus to treat conditions of thenaso-pharyngeal area) or other implanted material US patent applicationNo. 20050004417A1 (Devices, systems, and methods to fixate tissue withinthe regions of body, such as the pharyngeal conduit).

Neuroprosthetic Devices

Various neuroprosthetic devices have been invented that stimulate upperairway muscles. U.S. Pat. No. 4,907,602 to Sanders describestransmucosal stimulation to dilate the airway; U.S. Pat. No. 5,792,067to Karell teaches an intraoral device that applies electricalstimulation to the hard palate, soft palate or pharyngeal area to inducecontraction of the upper airway muscles; U.S. Pat. No. 5,190,053 to Meerteaches an intraoral device that applies electrical stimulation to thegenioglossus muscle via electrodes located on the mucosa on the floor ofthe mouth on either side of the frenulum. In addition U.S. Pat. No.5,591,216 to Testerman describes a totally implantable device tostimulate the nerves to the genioglossus muscles. In addition, WIPOapplication No 04064729 to Gordon describes a neuroprosthetic devicethat can be injected into the soft palate to treat snoring. At presentthese devices have not been clinically proven.

In summary, sleep disorders are a significant health problem without anacceptable solution and there is a need in the art for new and moreeffective therapies.

While not wishing to be bound by theory my studies of human tongueanatomy suggest that episodes of obstruction evolve by a sequence ofevents (FIG. 4). The initial inciting event is the deformation of arelatively small part of the tongue. Under certain conditionsdeformation begins in soft tissue on the top of the tongue, particularlyin the area of the tongue curve, and specifically near the center lineof the tongue curve. As this tissue deforms it narrows the airway andcauses more negative pressure thereby causing greater deformation. Thisfeedback cycle in turn deforms enough tissue in the area to cause acomplete obstruction in the velopharyngeal area. If an initialobstruction occurs near the end of inspiration, the obstruction isrelieved by an expiration, or by action of the genioglossus muscle.However, if the obstruction occurs at the beginning of inspirationreflexes trigger stronger inspiratory effort that further lowers airwaypressure. This increased negative pressure causes deformation andcollapse of most of the tongue base. At this point the airway is firmlyplugged by soft issue and activity of the genioglossus only stretchesthe tongue tissue that is plugged and cannot dislodge it.

Therefore the tongue curve is the critical area that initiates thecascade leading to obstruction. This relaxed muscle is very flexible andeasy to deform, however, the converse is also true, and very littleforce is needed to prevent this deformation. Therefore if sufficientcounterforce is exerted at the proper localized area of the tongue itcan prevent obstruction without noticeable effects on speech andswallowing movements.

How a device could prevent the deformation and collapse of the tonguecurve is not a trivial problem:

-   -   This area of the tongue is very mobile during speech and        swallowing, therefore the amount of force exerted must be low        and highly localized. It is unacceptable to render the area        immobile, as would be done if were stiffened by a large implant        or scar tissue.    -   Moreover the whole area of the velopharynx has extensive sensory        innervation, and relatively minor stimulation there causes        either a gag or a swallow.    -   In addition the tongue base and body have a larger blood supply        than comparable muscles elsewhere in the body. Any implant        placed in the area has a high probability of causing internal        bleeding with potentially catastrophic tongue swelling.    -   Finally, OSAS patients have borderline airways that can obstruct        after even minor amounts of swelling such as that following        surgical manipulation. Therefore it not obvious how a device        could both exert force in the area yet avoid swelling.

Moreover to be maximally effective and get patient and physicianacceptance the device would ideally have additional qualities:

-   -   It should be capable of being inserted as an outpatient        procedure.    -   Preferably the device could be removed during the day and        reinserted by the patient at night.    -   It would be adjustable to conform to the specific needs of the        patient.    -   It would be comfortable for the patient.    -   When the device was in place it would not be noticeable to        anyone else.

SUMMARY OF THE INVENTION

The invention comprises a method and device for the treatment of OSASand its symptoms such as snoring. In the preferred embodiment the deviceis inserted into the tongue to treat patients with OSAS. This patientpopulation has serious medical problems and few treatment options.

The method counteracts the deforming influence of negative airwaypressure on the relaxed soft tissue of upper airway structures. Thesestructures include, without limitation, the tongue, soft palate,pharyngeal walls and supraglottic larynx. The soft tissue is retractedby a device implanted in tissue (FIG. 14). In turn the retractor ismechanically connected to another soft tissue site, preferably a musclethat continues to contract during inspiration. By this method the deviceeffectively prevents airway obstruction during sleep. The device iscomposed of three distinct parts. A retractor is physically coupled tothe relaxed soft tissue area. A shaft connects the retractor to ananchor. The anchor imparts counterforce through the shaft to theretractor, thereby preventing deformation of the soft tissue.

By extensive study of the internal anatomy of the tongue I havediscovered that certain areas of the tongue have little or novasculature or nerve structures. Most importantly the entire midline inthe tongue body has few vital structures. In the preferred embodiment adevice could be placed through the centerline of the tongue without riskof causing damage to blood vessels or nerves. Although there are otherroutes through the tongue that avoid vital structures the centerline ismost preferred because the most deformable part of the tongue curve isalong the centerline. Surprisingly then, a device can be placed directlythrough the tongue to the area most vulnerable to OSAS with minimalrisk.

In the preferred embodiment the device comprises a hollow flexible shaftwith an inflatable balloon at each end. To insert the device it isslipped over a needle and the balloons are deflated. The combined deviceand needle then is passed directly through tongue tissue such that theretractor balloon presses on the base of the tongue while the anchorballoon provides counterforce by its design as well as its position inthe genioglossus muscle. The mechanical counterforce preventsdeformation of the relaxed tongue during sleep.

The device conveys enough force to maintain the tongue curve in itsneutral position during sleep. However, during speech and swallowing thetongue base moves both forward and backward from the neutral position.These movements are quite strong, for example the movement of the tonguebase during swallowing exerts about ten times more force than thatneeded to keep the relaxed tongue in the neutral position. Therefore thedevice is designed to limit its force and allow free movement of thetongue base during speech and swallowing.

An advantage of the invention over the prior art is that, unlike currentsurgical procedures and devices for OSAS, the invention acts on a smalland localized area, rather than on the entire upper airway structure.Therefore the invention is effective without significantly impairingnormal function. As the device is inserted by a needle there is minimalpost procedure pain or swelling, therefore the procedure can beperformed in an outpatient environment.

A further advantage over prior art is that as soon as the device isinserted it allows the physician to control the airway, imparting alevel of security against serious complications. In an emergency it canbe grasped at its anchor end under the tongue and manually retracted toenlarge the airway. This will help prevent the potentially lethal airwayobstructions to which severe OSAS patients are susceptible.

Further advantages over prior art is that the device is adjustable andcompletely removable. Once the physician has made the initial insertion,and the tract matures, the device can be removed by the patient in themorning and reinserted at night. After insertion the patient can adjustthe tension of the device for maximum effectiveness and comfort. As thedevice is inserted from beneath the tongue and exits near the tonguebase it is not easily seen by other people. Finally, an advantage of theinvention is that it is inexpensive relative to current treatments forOSAS.

Although the preferred embodiment of the invention is implanted intongue, alternative embodiments can also be used to treat lax softtissue of the soft palate, pharngeal walls and larynx that impinge onthe airway.

Further alternative embodiments of the device have beneficial uses. Ifits shaft is hollow it serves as a conduit through the tongue. In thisway a connection is made between the oral and pharyngeal cavitiesthrough which air pressure is equalized, thereby helping to preventOSAS. Still further embodiments utilize the conduit to supply air atpositive pressure to the pharynx.

In further alternative embodiments the open conduit can serve as an easypathway for accessing the pharyngeal cavity and neighboring structures.Catheters can be passed to suction secretions from the pharynx andlungs, or pass feeding tubes into the stomach. Endoscopic surgicalinstruments can be passed into the pharynx and neighboring structures toperform surgical procedures.

In further alternative embodiments the conduit can serve to storemedical sensing or diagnostic instruments or pass them into the pharynx.Examples include sensing oxygen or carbon dioxide levels of arterial orvenous blood, airflow or vibration. These sensors can transmitphysiological data to a receiver outside the body or used to controlother implanted medical devices.

It is an object of the invention to provide a conduit to housetherapeutic equipment such as neuroprosthetic sensors and/orstimulators. These could be used to stimulate the tongue nerves ormuscles to improve swallowing or speech function of the tongue.

Finally, drugs can be stored in the conduit and to be delivered locallyto the mouth or pharynx; non-limiting examples are antibiotics forperiodontal disease and antifungal medication for oral candidiasis.Alternatively the drugs could be released across the walls of the deviceinto surrounding tissue. As there is tremendous blood supply to thetongue the medication could enter the systemic circulation rapidly. Nonlimiting examples include insulin to treat diabetes and radioactivematerial or chemotherapeutic agents for therapy of cancer.

OBJECTS AND ADVANTAGES OF THE INVENTION

It is an object of the invention to provide a method and device for thetreatment of OSAS.

A further object of the invention is to retract or prevent thedeformation of tongue, soft palate, pharyngeal wall and/or laryngealsoft tissue, thereby treating OSAS.

It is an object of an alternative embodiment of the invention to providea conduit through the tongue for therapeutic or diagnostic purposes.

BRIEF SUMMARY OF THE DRAWINGS

FIG. 1 is a drawing of the human upper airway in the mid saggital plane.

FIG. 2 is a simplified schematic drawing of the tongue and surroundingstructures.

FIG. 3 is anatomical landmarks of the tongue.

FIG. 4 is a mechanism of airway obstruction.

FIG. 5 is a tongue retractor.

FIG. 6. A, B is an insertion of device.

FIG. 6. C, D is an inflation mechanism for device balloons.

FIG. 7. A, B is an anchor balloon mechanism of action.

FIG. 8. A, B, C, D is an alternative embodiment of device.

FIG. 9. A, B, C, D is an alternative locations of the device in thetongue.

FIG. 10 is an alternative embodiments in other soft tissue organs.

FIG. 11. A, B, C, D is a totally implanted embodiment of the device.

FIG. 12 is an Alternative embodiment of the device as a conduit.

FIG. 13. A, B is an Embodiment as a conduit for gastric and pulmonarytubes.

FIG. 14 is a retraction of tongue curve.

FIG. 15 A, B, C, D is the alternative embodiments as a collapsableconduit.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 2. Simplified schematic drawing of the tongue and surroundingstructures

NP, Nasopharynx

VP, Velopharyrnx

HP, Hypopharynx

SP, Soft palate

P, Hard palate

T, Tongue

GG, Genioglossus muscle

FIG. 3. Anatomical landmarks of the tongue.

The part of the tongue that relaxes during sleep is shaded in thisschematic drawing. The genioglossus muscle (GG), that does remain activeduring sleep, inserts into a connective tissue boundary on theundersurface of the tongue (Bo).

BA) Tongue base

BD) Tongue body

BL) Tongue blade

Bo) Boundary between tongue and genioglossus

C) Tongue curve

F) Frenulum

GG) Genioglossus muscle

FIG. 4. Mechanism of airway obstruction.

A) Normal tone in tongue while awake. Tongue remains in positionallowing airway to remain open.

B) During sleep muscle tone is lost and the soft tissue of the tonguebecomes flaccid. Negative pressure in the pharynx during inspirationcauses collapse of the tongue in the velopharyngeal area because theairway is narrowest at that point and the tongue curve (circle) is mostdeformable.

C) Once obstruction occurs at any point along the upper airwayinspiration lowers the pharyngeal pressure causing collapse of othersoft tissue structures, particularly the tongue base (circle).

D) Tongue retractor in place preventing posterior deformation of tonguecurve.

FIG. 5. Tongue retractor.

r, retractor balloon,

s, shaft,

t, tube,

a, anchor,

i, injection port,

n, needle,

h, handle

FIG. 6. A, B. Insertion of device.

The combined device and trocar is passed through the tongue (A). Theballoons are then inflated to secure the device in place (B).

FIG. 6. C,D. Inflation mechanism for device balloons.

C) The balloons can be separately inflated but preferably they areconnected by a small tube (t) that passes between them on the side ofthe shaft (s). The tube has an open port at its terminal end within eachballoon thereby allowing free passage of fluid or air.

D) The anchor balloon is inflated or deflated by an injection needlethat passes through a resealable diaphragm (d) and this diaphragm isheld in place by a collar (c) that in turn connects to the balloonmembrane. p, open end of tube d, diaphragm, c, collar.

FIG. 7. A,B. Anchor balloon mechanism of action.

Counterforce is adjustable by inflating or deflating the anchor balloon.Tongue tissue has some resistance to being separated. The anchor balloonhas a wedge shape (A) that widens as pressure within the balloonincreases. By this method the angle of the wedge can be increased,thereby causing a proportional increase in the tissue force against theanchor balloon, which is the counterforce conveyed to the retractingballoon via the shaft. The amount of counterforce needed to keep therelaxed tongue base in position is low. While tongue movements such asswallowing exert very large forces as the tongue moves backward. Atmaximum inflation the anchor balloon still exerts much less counterforcethan the tongue during swallowing. Therefore the anchor balloon canslide into the tongue tissue (7 B, arrow) to allow backward movement ofthe tongue base without impairing the normal tongue movements.

FIG. 8. A,B,C,D. Alternative embodiment of device.

There are multiple alternative embodiments of the device that do not useballoons or any hydraulic mechanism. Shown is an example of oneembodiment.

FIG. 9. A,B,C,D. Alternative locations of the device in the tongue.

The device can be oriented in alternative locations within the tongueand yet achieve the goals of preventing tissue deformation. A) Theretractor is placed at the tongue curve and the anchor is placed on thesame side in tongue blade.

B) Two “anchor” ends on either side of frenulum. The shaft is flexibleand loops beneath the tongue curve. In this embodiment the shaftfunctions like an implanted retractor.

C.) Entire device implanted within the tongue.

D) Device anchor outside of neck

FIG. 10. Alternative embodiments in other soft tissue organs.

PR, pharyngeal wall retractor;SR, soft palate retractor;LR, laryngeal soft tissue retractor

FIG. 11. Alternative embodiment as a conduit

FIG. 11. A,B,C,D. Totally implanted embodiment of the device.

In one alternative embodiment the entire device is implanted. Implanteddevices can have anchor or retractor members that interact with tissuedifferently then those used on the mucosal surface. In this example thedevice both the retractor and anchor have an arrow shape, with thearrows acting as hooks. The shaft is 2 cm in length and is stretcheseasily. The entire device is preferably made a single continuousflexible structure. The device is inserted into the bore of needle (Bside view of needle, C device inserted in needle). The needle is theninserted to the proper depth within tissue and withdrawn.

FIG. 12. Alternative embodiment of the device as a conduit.

FIG. 13. A,B. Embodiment as a conduit for gastric and pulmonary tubes.

GT, Gastric Tube

PT, Pulmonary tube

FIG. 14. Retraction of tongue curve.

Shown is the oral cavity of a dog, the tongue is at the bottom of thephotos and the palate is at the top. The arrow points to the airway. A)The flaccid tongue obstructs the airway. A prototype of the retactor hasbeen inserted in the dog's equivalent of the tongue curve and only it'sedge is visible {r}. With minimal counterforce on the retractor head theairway lumen is restored.

FIG. 15. Alternative embodiments as a collapsable conduit.

A) A device with flexible walls collapses after insertion (cc). Thedevice maintains the conduit through the tongue. A resealable cap can beopened to pass medical devices through the conduit (rc).

B) Example of a ventilation tube passed through the conduit. An airwayballoon (ab) can be inflated to form a seal so that the patient can beventilated with pressurized air (pa).

C) Example of a suction tube (St) passed through the conduit. A vacuumsource (v) suctions secretions from the pharynx.

D) Example of surgical conduits (sc) placed to allow passage ofendoscopic surgical instruments into the pharynx and neighboringstructures.

cc, collapsible conduit (cc)rc, resealable capab, airway ballonpa, pressurized airv, vacuum sourcest, suction tubesc, surgical conduit

DETAILED DESCRIPTION OF THE INVENTION Definitions

“Tongue curve” refers to the area of the tongue where it's superiorsurface curves from a horizontal orientation (tongue body and blade) toa vertical orientation (tongue base). Preferably tongue curve refers tothe soft tissue in this area between the mucosal covering of the tongueand the connective tissue boundary where the genioglossus muscleattaches.

“Tongue blade” refers to the part of the tongue anterior to thefrenulum. It is covered by mucosa on its top, sides and undersurface.

“Tongue body” is the mid part of the tongue located between the tongueblade and tongue base.

“Tongue base” refers to the part of the tongue posterior to the tonguecurve. In anatomical terms the line of demarcation of the tongue base isthe circumvalatte papillae, a grossly visible line of raised tasteorgans on the superior surface of the tongue.

“Conduit” refers to one embodiment of the invention wherein the shaft ishollow and once implanted there is continuity between the air spaces onboth ends of the device. Preferably these air spaces are the pharynx atthe retractor end and the oral cavity at the anchor end.

“Collapsable conduit” refers to one embodiment of the invention wheremost components of the device, most preferably the shaft collapse afterinsertion due to surrounding tissue pressure. Preferable these conduitsserve as guides for other devices to be passed through, preferablysuction and feeding tubes, ventilation tubes, and endoscopic surgicaldevices.

“Frenulum” refers to the vertical anterior edge of the genioglossusmuscle. The frenulum passes from the floor of the mouth up to thecenterline of the underside of the tongue. The frenulum marks theboundary between the tongue blade and tongue body.

“Tongue boundary” or “boundary” is the inferior surface of the tonguebady and base. The genioglossus muscle inserts onto a large part of theboundary.

“Deformation” refers to an abnormal change in the shape of upper airwaysoft tissue structures. This deformation is preferably due to negativepressure acting on relaxed upper airway structures during sleep causingthem to narrow the upper airway. Most preferably this soft tissue is thetongue curve.

“Reverse deformation” refers to a change in soft tissue shape caused bythe tissue retractor. In some embodiments reverse deformation refers torestoring a deformed structure to its normal shape. In other embodimentsreverse deformation refers to an indentation of soft tissue in a givenarea due to the action of a tissue retractor.

“Tissue retractor” refers to the complete device of the invention forthe prevention of soft tissue deformation. The device may be usedwithout limitation in the tongue, soft palate, or pharyngeal walls.

“Tongue retractor” refers to a complete device used for the preventionof tongue deformation. Preferentially it comprises a retractor connectedto a shaft which in turn is connected to an anchor.

“Palate retractor” refers to a complete device used for the preventionsoft palate deformation.

“Pharyngeal wall retractor” refers to a complete device for theprevention of pharyngeal wall deformation.

“Laryngeal retractor” refers to a complete device for the prevention oflaryngeal soft tissue deformation.

“Retractor” or “retractor head” or “retractor member” refers to a partof the overall tissue retractor. The retractor physically interacts withsoft tissue, either directly or indirectly, to prevent it fromdeforming. In certain embodiments the retractor head is a disc locatedon the external surface of the tongue, in other embodiments therefractor head is an inflatable balloon, in other embodiments theretractor head may have curved parts that act like hooks, in otherembodiments the retractor head may be a flexible wire passing throughthe tissue. In some embodiments it may be totally implanted withintissue.

“Retractor shaft”, “shaft” or “retractor member” refers to that part ofthe tongue retractor that attaches to the retractor head and serves toconnect it to the retractor anchor. In some embodiments the retractor Indifferent embodiments the shaft may be rigid or flexible, solid orhollow, one piece or multiple linked pieces.

“Retractor anchor”, “anchor” or “anchor member” refers to a component ofthe device that physically interacts with tissue to provide counterforceto the retractor.

EXAMPLE 1 Preferred Embodiment of the Invention

In its preferred embodiment the device is composed by a thin flexiblehollow shaft with inflatable balloons as retractor and anchor members(FIG. 5 A). The materials and manufacture of such a device is well knownin the art as exemplified by angioplasty catheters, tracheotomy tubes,jejunostomy tubes and other biocompatible medical devices that aretemporarily or permanently implanted within body tissue. Asrepresentative examples of the art, U.S. Pat. No. 3,659,612 to Shileydescribes a cannula that is placed in the trachea with a refillableballoon at its internal end; U.S. Pat. No. 4,335,723 to Patel describesthe use of thermoplastic elastomer material for balloon cathers; U.S.Pat. No. 6,013,728 to Chen describes biocompatible polymers used inconstruction of vascular catheters and expansion balloons, U.S. Pat. No.4,254,774 to Beritos teaches the manufacture of catheters with externaldiameters less than 1 mm and external balloons with walls less than0.002 inches in thickness.

Preferably the retractor is a spherical balloon which has a diameter of0.5 cm when inflated. The force that acts on the balloon comes from a 5cm long shaft with an external diameter of 2 mm that passes through thecenter of the balloon. The retractor balloon is attached to the shaft intwo places, where the shaft enters the balloon and at the tip of theshaft. These attachments are airtight and securely connect the balloonto the shaft.

At the exit of the shaft from the tongue there is a second balloonattached that serves as an anchor. The anchor balloon is 1 cm long andtapered with its narrow end embedded in tissue and the wider end outsidetissue. The taper is a wedge which resists the anchor from being drawninto the tongue (FIG. 7). When the patient swallows the tongue curverises and the anchor balloon is drawn into the tongue. After the swallowthe anchor balloon gently repositions the device. The amount ofresistance and counterforce provided by the anchor balloon is directlyrelated to its degree of inflation. The greater the volume of air in theballoon the greater the resistance of the balloon to being drawn intothe tongue.

The force imparted to the balloon indents the tissue at the tongue curveand prevents it from deforming and collapsing into the airway undernegative pressure. This force is conveyed to the balloon by the shaft.This shaft passes through the center of the tongue to exit from the itsundersurface at the point where the frenulum connects to the tongueblade.

The shaft is hollow with an internal diameter of 1 mm to allow it to bemounted over a trocar needle for insertion (FIG. 5). When the balloonsare deflated they lie flush against the shaft such that the shaft has asmooth surface. In the deflated condition the device can be easilyinserted or removed from the tongue. For example, in the morning theballoons can be deflated to slide the entire device out of the tongue.The presence of a tapered anchor balloon causes slight widening of thetongue tissue at its exit from the tongue. After a week this widening ofthe tissue is maintained even if the device is removed for a day andserves to easily guide the device into its tissue conduit. When theretractor tip is passed through the tongue and exits from the tonguebase the balloons can be inflated to a proper size that is effective yetcomfortable for the patient.

The balloons can be inflated separately or more preferably they areconnected by a small tube that runs along the side of the shaft (FIG.6). In this manner inflation of the anchor balloon, which is easilyaccessed by the patient, also inflates the retractor balloon. The anchorballoon has a small resealable rubber diaphragm through which a needlecan be inserted to insert or remove air or liquid. U.S. Pat. No.4,387,879 to Tauschinski describes a self-sealing connector for use withplastic cannulas and vessel catheters, U.S. Pat. No. 5,498,247 toBrimhall describes an elastomeric injection port that reseals afterneedle punctures for injection of fluid. A variety of other reusableinterfaces for transferring air or fluid are known in the art and can besubstituted.

A non-limiting example of the method of this invention is described. A60 year male complains of awakening during the night with chokingsensations, morning headaches, daytime sleepiness, difficulty inconcentrating, irritability and acid reflux. Physical examination showsmoderate obesity, an elongated soft palate and enlarged tongue base.Endoscopy shows diffuse mild swelling and redness throughout hispharyngeal mucosa. The area of the velopharynx is notably narrow andcollapses when the patient attempts a forceful inspiration. The patienthas a sleep study performed that shows he has obstructive sleep apneawith an apnea-hypopnea index of 30 with episodes of oxygen desaturation.

After discussing the therapeutic options with his physician he elects totry CPAP. He then undergoes a second overnight sleep study with CPAPtesting and titration of pressure. He is found to have the best responsea CPAP pressure of 14 cm of water. He obtains a CPAP machine and isinstructed on its use. The patient finds that the device isuncomfortable, he complains of feeling claustrophobic and that it isdifficult to maintain an airtight seal of the mask on his facethroughout the night.

The patient requests that a tongue retractor be inserted. The procedureis performed in an ambulatory surgical center under mild sedation andwith continuous monitoring of electrocardiogram and oxygen saturation.

A small amount of 1% lidocaine is sprayed onto the inferior surface ofthe patient's tongue to provide surface anesthesia. Using a 1 cc syringewith a 30 gauge needle the intended insertion tract in injected withsuitable local anesthetic, preferably 1% lidocaine with 1:100,000epinephrine. The needle is passed through the tongue from theundersurface to the tongue base and the anesthetic is injected.

After allowing 10 minutes for onset of the anesthetic action thephysician gently grasps the tongue blade with a cotton 4×4 and lifts itto expose the undersurface of the tongue.

For initial insertion of the device it is mounted on a 5.25 cm trocarneedle with a 1 mm external diameter. After the trocar is based throughthe hollow core of the device it covers the entire length of the trocarneedle except thee tapered tip that projects 0.25 cm beyond the device.

The initial insertion point is at the junction of the frenulum with thetongue blade. The tip of the needle in inserted into the frenulum andoriented toward the tongue curve. The device is advanced slowly untilit's tip is seen exiting the base of the tongue. The needle is pushedfurther until the retractor balloon is seen and then the needle isremoved while the position of the device is maintained by holding theanchor. Once the needle is removed the balloons are inflated byinjecting 2 cc of air though the resealable injection port. The patientis observed for 2 hours to ensure that no significant swelling occursand then is sent home with mild analgesics and antibiotics for 3 days.Every morning the patient removes 1 cc of air from the device todecrease the size of the balloons so that the device is morecomfortable. In the evening he reinjects 1 cc of air into the device.

After 1 week the patient returns to his physician for follow-up andreports that he has been sleeping well without awakening during thenight and that feels well rested each morning without any headaches. Hiswife has told him that she has not noticed any snoring. The patient alsonotes that symptoms of acid reflux have decreased. The physiciandeflates the balloons and removes the device. He examines the openingsof the tongue tract for any sign of infection or erosion. The physicianthen instructs the patient on how to remove and replace the device. Fromthen on the patient completely deflates the balloons each morning andextracts the device by pulling on the anchor. In the evening he threadsthe retractor end into the tract opening underneath his tongue and thenreinjects 2 cc of air.

This example is illustrative of a preferred embodiment and is notlimiting. Non-limiting alternative embodiments include devicescontaining 1 to 10 balloons or a single balloon spanning the length ofthe shaft. The shaft itself may be composed of a solid or hollowcylindrical balloon. Those skilled in the art can perform the method ofthe device without undo experimentation. The device itself can bemodified by the use of a variety of materials, and shape and nature ofits components can be readily varied in multiple ways by those skilledin the art.

EXAMPLE 2 Alternative Embodiment (FIG. 8)

In another embodiment of the invention used in the tongue the tongueretractor consists of a small flexible disc to which the retractor shaftconnects in the center of one surface. This shaft would have a terminalend to which an anchor attached.

The disc would preferably be elliptical with a 1 cm long axis orientedalong the centerline of the tongue, and a 5 mm short axis orientedperpendicular to the centerline. Preferably the undersurface of theretaining disc would have a slight taper in thickness from the lateraledges to the centerline.

The retaining disc would lay flush against the tongue surface and exerta small amount of force to prevent deformation of this area. Morecounterforce would cause an indentation or reverse deformation of thetongue curve (FIG. 8 D). This reverse deformation would maintain an openconduit so that even if the tongue were to collapse against the pharynxor soft palate, there would never be complete obstruction.

Preferably the disc would be composed of soft and pliable biocompatiblematerial so that it can exert pressure onto tongue mucosa withoutcausing tissue damage. The amount of pressure that an implant can exertwithout causing damage is largely related to the pressure at which bloodflow is compromised. For the purpose of retaining the tongue curve thecounter pressure is preferably 0.01 to 1000 grams per cm², morepreferably 0.1 to 100 grams per cm², and most preferably 1 to 10 gramsper cm².

The shaft would pass through the body of the tongue and exit through itsundersurface. Preferably the shaft would be solid yet flexible, able todeform in shear and strain. This would allow the shaft to flex duringwhen tongue movements cause internal changes in relative position alongits length.

Preferably the shaft would be able to stretch. More preferably the shaftwould be very compliant, able to easily stretch during forcefulmovements of the tongue base during speech and swallowing, yet retainsufficient strength to prevent deformation of the relaxed tongue curveduring sleep. The force exerted by the tongue during swallowing has beenmeasured to be approximately 100 grams per cm² (Proffit, W. R., Musclepressures and tooth position: a review of current research. Aust.Orthod, J., 1973. 3: p. 104-108). Preferably the resistance to stretchwould be adjustable by intrinsic qualities of the shaft. Non-limitingexamples being the presence of a spring or by the use of elastomericmaterials. In other embodiments the adjustment in tension and movementwould be imparted by the anchor. A non-limiting example is a wedge shapesimilar to that described for the anchor balloon in the preferredembodiment.

Preferably the length of the shaft would be 1 mm to 20 cm, morepreferable 1 to 10 cm and most preferably 5 cm. The diameter of theshaft could be from 0.1 mm to 5 cm. 1 mm in diameter and circular incross section throughout most of its length.

Preferably the proximal end of the shaft has an anchor is detachable.The mechanism of attachment could be by screw, clip, ratchet, magnet, orother mechanism known in the art. In this manner the anchor could beeither easily unattached from the anchor. When unattached the retractorhead and shaft would preferably remain in position within the tongue.Preferably there would be a small flange on the anchor end of the shaftsuch as illustrated in FIG. 11 A.

If desired the device could be removed in its entirety during the day.After a period of time conduits that pass through body tissues becomemature, that is they do not close immediately when the external objectis removed temporarily. Therefore the device could be removed in themorning by pulling on the retaining disc leaving only the collapsedtract through tongue tissue. The following night the distal end would beagain threaded through this tract into position and secured to theanchor.

EXAMPLE 3 Alternative Embodiments Related to Soft Tissue Location

Although the tongue is the major cause of OSAS other soft tissuestructures also contribute. Alternative embodiments of this inventioncan be used to prevent the deformation of lax soft tissue in theseorgans.

a) Placement of the Device in the Softpalate.

An elongated or thickened soft palate often contributes to OSAS orsnoring. One embodiment of the invention is to reversible retract thesoft palate tissue away from the area of obstruction to treat OSAS orsnoring. Another object of the invention is to stiffen the soft palateto dampen its oscillation to prevent snoring. A preferred embodiment ofthe device in the soft palate would have a retractor on the externalsurface of the free end of the soft palate and a shaft passing forwardwithin the soft palate to an anchor on the external surface of the softpalate near the hard palate (FIG. 10, SR). Numerous embodiments thatachieve the object of the invention can be understood by those skilledin the art.

b) Placement of the Device in the Pharyngeal Walls

In certain cases excess soft tissue of the pharyngeal walls contributesto airway narrowing. The device can be inserted in pharyngeal walls toretract excess soft tissue away from the areas of obstruction (FIG. 10,SR).

c) Placement of the Device in Laryngeal Soft Tissue.

In certain cases the larynx contributes to OSAS. The epiglottis can beflail and rest against the posterior pharyngeal wall, or the soft tissueconnected to the epiglottis, the aryepiglottic folds and vallecula, canbe swollen. The internal side of these structures contains a densesensory innervation and is hot a preferred location for retractormember. Most preferred is the mucosa of the vallecula, the area betweenthe epiglottis and the tongue base. Retraction of this location raisesthe epiglottis and stiffens the soft tissue of the larynx.

EXAMPLE 4 Alternative Embodiment that is Implanted within Soft Tissue

There are advantages to having the device pass completely through anupper airway organ. Without limitation these include easy access to theretractor and anchor components and the ability to easily remove thedevice. However, this is not essential. The device could also becompletely implanted within tissue. Although not wishing to be bound bytheory, the important action of the invention is to mechanically couplethe soft tissue of a structure that relaxes during sleep to anotherstructure. Preferably the second structure is an external muscle thatremains active during sleep (genioglossus, geniohyoid, myelohyoid,digastric muscle) thereby providing active retraction. Other muscleswithin the neck (strenohyoid, sternothyroid, thryohyoid) and chest(diaphragm intercostals) could also be use however these would requirelong shafts. In the tongue one embodiment is a retractor implanted inthe soft tissue of the tongue curve that is connected by a shaft to ananchor embedded in the genioglossus muscle (FIG. 9 C).

External retractors and anchors pull on mucosa and the underlying softtissue. Their preferred mechanical interaction is to distribute forcealong a surface interface so as not cause pressure necrosis to tissue.In contrast, implanted embodiments can mechanically interface withtissue in additional ways.

FIG. 11 is an illustrative example of a an implantable device that hashook elements as both retractor and anchor components (FIG. 11A). Theimplanted device can be inserted using a hollow bore needle (FIG. 11 B)by placing the device such that the retractor end hooks extend laterallyout from the opening of the needle near the tip (FIG. 11 C). Insertioncan be done by piercing the mucosa at the site of insertion and passingthe needle tip to the preferred depth. Then when the needle is withdrawnthe hooks of the retractor grab tissue and pull the device out of theneedle bore when the needle is withdrawn.

FIG. 11 D illustrates a preferred position and orientation within thetongue. The retractor hooks interface on soft tissue within the tongueso that they directly and indirectly can retract the tongue curve. Theanchor hooks interface with the genioglossus muscle. During sleep thecontraction of the genioglossus muscle actively retracts the tonguecurve.

EXAMPLE 5 Further Alternative Embodiments

The retractor components could vary in their number, position, materialcomposition, mechanical properties, shape, dimensions, and the manner ofattachment of the components to each other (permanent to removable).

In some embodiments the materials of the device could be flexible,non-limiting examples being silastic, teflon, or nylon. In otherembodiments the materials could be rigid, non-limiting examples beingstainless steel or titanium. In some embodiments different componentsare composed of different materials. Many biocompatible materials areknown in the art that could be used. (Ratner et al, BiomaterialsScience, Academic Press San Diego 1996). The materials used may benatural body substances, two common proteins used for implantationwithin the body are collagen and elastin and examples of the art usingthese materials are U.S. Pat. No. 5,989,244 to Gregory that describesthe use of elastin as a material for implanted devices and U.S. Pat. No.5,376,110 to Tu describing methods of preparing collagen for implants.

Preferably the retractor, anchor and shaft would be molded as a singlecontinuous structure such that this junction would be less likely tohave small niches where biological debris and bacteria could accumulate.In other embodiments components could be detachable. Many mechanisms forreversible mechanical detachment are known in the art, one non-limitingexample is the presence of threads on the end of the shaft and in thecenter of the retractor head, such that that retractor head could bescrewed onto the shaft like a nut onto a bolt.

In different embodiments the shape and size of the retractor wouldpreferably reflect the anatomy of the region. In certain embodiments theretractor presses on the mucosal surface of the tongue, soft palate,pharyngeal walls, or supraglottic larynx. In these different embodimentsthe size and shape of the retractor could vary to conform to the shapeof the surface that its rests against. Preferably the retractor woulddistribute force to the mucosa evenly to minimize tissue trauma. Thelargest diameter of the retractor head could range from 0.1 mm to 10 cm,preferably 1 mm to 1 cm and most preferably 5 mm.

The anchor serves to provide counterforce to the retractor during sleep.In a preferred embodiment the surface area of the bolster is the same orgreater than the retractor thereby distributing the forces over a largerarea. In some embodiments the anchor would serve to allow adjustment oftension between the anchor and the retractor.

In alternative embodiments the length of the shaft could vary from 0.1mm to 20 cm, preferably 1 mm to 10 cm, and most preferably 1 to 5 cm.The diameter of the shaft could range from 0.01 mm to 100 mm, morepreferably 0.1 mm to 10 mm, and most preferrably 1 mm to 5 mm. The shaftcould have a hollow core that extends from one end of the shaft to theother, in other embodiments only a segment of the shaft would be hollow,or the shaft would be solid with no hollow core. The diameter of theshaft could taper with the largest diameter at one end with decreasingdiameter toward the other end, largest diameter in the center withnarrowing toward each end or smallest diameter in the center withincreasing diameters toward each end.

The position and orientation of the shaft could vary. The retractor headcould be placed at other points along the midline of the tongue. Theangle of the shaft could vary. In addition the shaft could be angledlaterally to exit at any point lateral to the midline. The course of theshaft need not remain constant. It could start at one orientation andchange to another.

In some embodiments the adjustment of tension between the retractor andthe anchor would involve mechanically coupling the anchor to anotherobject. This object could be another device implanted in another softtissue area, teeth or dental appliances attached to the teeth, orobjects external to the mouth. The component attaching the anchor to asecond object could be a rubber band, a wire, string, chain, rod.Attachments could be by hooks, clips, magnets or other mechanicalcoupling methods known in the art.

One or both of the retaining components could be implanted such that theentire device would be implanted beneath the mucosa. In anotherembodiment, one end would be implanted and the other exit externally.

There could be multiple retractor heads and shafts in variouscombination. As an example a single retractor head at the tongue basecould attach to two or more shafts. Areas through which the implantmight be placed include the tongue, velopharyngeal, hypopharyngeal andnasopharyngeal walls, including the cheeks, hard and soft palate, andfloor of the mouth. There may be one or more implants. The implant mayretract the tissue by itself because of the area it is placed or may beattached to an another object by solid rods, wires, rubber bands. Nonlimiting examples are another device in the soft palate, cheek or lip,the teeth or intraoral dental devices, in addition the device can beattached to objects external to the mouth.

EXAMPLE 6 The Device as a Conduit Between the Oral Cavity and Pharynx

In an alternative embodiment of the invention the shaft of the device ishollow and therefore functions as a conduit through the tongue. In thosecases the device would more preferably be placed lower and orientedhorizontally (FIG. 12). In this manner the shaft would pass parallel tothe horizontal part of the genioglossus muscle or even lower through thegeniohyoid or myelohyoid muscles. In this area of the tongue there isalmost no tongue displacement in the superior or lateral direction,almost all movement is to shorten or lengthen in the anterior toposterior direction. As a result the conduit is not exposed to strongflexing forces, thereby allowing it to have a large diameter withoutinterfering with tongue function.

In one alternative embodiment of the invention the shaft would berelatively larger and the retractor and anchor would be smaller,preferable reduced to a small flange around the edge of the openings toprevent the conduit from moving out of place (FIG. 12 A). The anchor endin the mouth could have a removable cap and/or a connector to interfacewith other devices.

In one embodiment the conduit between the pharynx and mouth would allowpassive equalization of air pressure in the pharyngeal space,attenuating the negative pressure that leads to collapse of thepharyngeal walls. Further embodiments would add mechanisms for sensingairflow or pressure that control a source of oxygen or air that could bedelivered through the conduit. An attachment to an external pressuresource could pump air to actively increase pharyngeal pressures. U.S.Pat. No. 5,954,050 to Christopher describes an invention where a conduitthrough the neck directly into the trachea is used to pass catheterscapable of sensing airflow, pressure or carbon dioxide levels of thetracheal. These signals are all relevant indicators of sleep apnea andother respiratory diseases. In turn these signals could be used tocontrol the delivery of oxygen or pressurized air.

A 60 year old male with severe obesity and OSAS yet declines a tongueretractor. Instead 1 cm removable conduit is be placed throughout themidline of the frenulum to the lower tongue base. The conduit is hollowand capped at the anterior end. At night the patient removes the cap andconnects a 2 foot extension that connects to a small ventilator thatdelivers air continually through the conduit. The ventilator can beadjusted to deliver air at positive pressure. In an alternativeembodiment the retractor end of the conduit has a sensor that measurespharyngeal pressure, carbon dioxide, and mechanical vibration, thesesignals are transferred to the ventilator by a wire running through theinside of the conduit and connection tubing, or sent by a small radiotransmitter. The ventilator is programmed to recognize acute increasesin negative pressure or carbon dioxide as indicative of airwayobstruction while mechanical vibration indicates snoring. The signalstriggers rapid delivery of air through the conduit to relieve thenegative pressure.

Still further alternative embodiments of the invention are to introducedevices through the conduit that control the airway. Preferably theseadditional devices would be similar to the laryngeal mask orendotracheal tube by having a mechanism, preferably an inflatableballoon, that would occlude the airway around the tube. In this manner acontrolled airway could be obtained for ventilation of the patient.

In further alternative embodiments the shaft of the conduit would behighly flexible so that after insertion it would be collapsed. However,an endotracheal tube or similar airway control device could be passedthrough the collapsed conduit easily. In this way patients who requiretemporary assisted ventilation could avoid having a tracheostomy tubeplaced (FIG. 15).

A non-limiting illustrative example is a 50 year old female with severemyasthenia gravis. The patient is able to breathe and swallow most ofthe time without assistance, however, almost every day she has periodswhere she feels weak and cannot breathe adequately. The patients has aconduit placed beneath her tongue in the centerline. The anchor is atthe anterior floor of the mouth and the shaft passes between thegenioglossus and geniohyoid muscles to the retractor end at the inferioraspect of the base of the tongue. The device is composed of softreinforced silastic with a constant fully expanded diameter of 1 cm,however, after placement the surrounding tissue pressure causes it tocollapse to a diameter of 2 mm. A cap that is also very flexible sealsthe anchor end. When not in use the device is comfortable and barelynoticed by the patient and cannot be seen by other people. When thepatient feels the need for assisted ventilation the cap can be opened toaccess the interior of the conduit. A ventilation tube of 8 mm externaldiameter is passed through the conduit into the hypopharynx. A balloonat the hypopharyngeal end of the ventilation tube can be inflated via aconnector at its anchor end. The inflated balloon largely but does notcompletely block the hypopharynx above the opening of the tube, so thereis some airleak when pressurized air is delivered through the tube. Thepatient connects the ventilator tube to a ventilator and adjusts therespiratory rate and tidal volume to comfortable levels. After two hoursthe patient feels stronger and turns the ventilator off, disconnects thetube, deflates the balloon and removes the ventilation tube.

EXAMPLE 7 Suctioning Secretions

Many patients with neurological diseases have difficulty swallowingtheir salivary secretions and are at risk of aspiration and pneumonia.Moreover, some patients have excess pulmonary secretions that theycannnot expell by themselves. It is well known in the art that suctioncatheters can be passed through the mouth or nose to suction secretions,however, these methods of suctioning secretions are extremelyuncomfortable and labor intensive. If these methods are insufficientsome patients undergo tracheotomy, intubation or other surgicalprocedures that allow more direct access for suctioning.

In an alternative embodiment the device can serve as a conduit to allowrelatively easy suctioning of secretions. A flexible suctioning cathetercould be inserted through the conduit to suction secretions from thehypopharynx or lungs. Alternatively an indwelling suction tube could bepassed through the conduit such that it lies in the hypopharynx. Theproximal end of said catheter is at the anchor end of the conduit andcan be secured to the conduit by many mechanical means well known in theart. When necessary a source of negative air pressure could be attachedto the conduit suction catheter. When not needed the negative pressuretube can be disconnected. In this manner suctioning could be easilyperformed at will with minimum discomfort to the patient. When theexternal tubing is disconnected the conduit would be unobtrusive.

In another embodiment of this invention a suction pump and energy supplyis incorporated into the device. Secretions are suctioned from the floorof the mouth through the anchor side of the device. These secretions arepassed to a catheter attached to the retractor end that passes into theesophagus or stomach. In this manner secretions are removed andappropriately delivered to the stomach before they cause a risk ofaspiration to the patient.

Methods and devices representative of the prior art include U.S. Pat.No. 3,517,669 to Buono describes a valved device for suctioningsecretions; U.S. Pat. No. 4,981,477 to Schon that describes a suctioncatheter for introduction into the trachea and the bronchial system;U.S. Pat. No. 5,694,922 describes metohds and devices for accessing theresouratory system to ventilate the lungs of the patient with gas orgases, to aspirate secretions from the lungs, to oxygenate the lungs toeliminate or reduce residual CO₂ therefrom, to visually inspect selectedparts of the respiratory system, to sample sputum and gases, to senseparameters such as flow rates, pressure, and temperature, to flush withwashing solution, and/or to administer medication, gases, and/or lavage.

EXAMPLE 8 Gastric or Pulmonary Tubes

Still another embodiment would be to use the device as an conduit forpassing other tubes to the pharynx, esophagus, stomach or lungs.

Many patients with impaired swallowing require direct tube feeding intotheir stomachs. If the need for a tube is temporary the tube is passedthrough the nose and into the stomach (nasogastric tube). Generally theproximal attachment end of the tube is taped securely to the nose andalso looped upward and taped directly to the face. At intervals liquidfeedings are attached to the nasogastric tube. U.S. Pat. No. 4,704,111to Moss describes one embodiment of a nasogastric feeding tube. If tubefeedings are needed for a prolonged period a tube can be surgicallyimplanted across the abdominal and into the stomach of small intestine(gastric tube). Both methods are uncomfortable, have significantcomplications, and impair the patient's mobility.

In one embodiment a thin wall tube could be passed through the shaft andextend into the esophagus or stomach (FIG. 13). In this embodimentdirect gastric feeding could be done, eliminating the need for anasogastric tube or percutaneous gastric tube. As the opening of thedevice is under the tongue it is not noticeable.

The implant may be temporary or permanent. It is one embodiment thatpart or all be removed during the day and replaced at night. The tissueconduit could be kept patent by a second item placed after the implantremoval that was more comfortable.

In another embodiment the conduit is used to pass a temporary orpermanent tube into the pharynx, larynx, trachea or lungs. Some patientswith lung disease need supplemental oxygen. In another embodiment thetube could deliver medication locally to the structures of the upperairway or lung.

EXAMPLE 9 Drug Delivery

The implant could also contain biologically active agents. Variousinventions are known that store medication in reservoirs or pumps forcontrolled release and these could be incorporated into an embodiment ofthis invention. As an example of the art U.S. Pat. No. 5,976,109 toHeruth describe an implantable drug reservoir.

Another embodiment would have a drug that is useful for an entirelydifferent purpose then sleep apnea. One example would be antibiotic forthe treatment of peri-dontal disease. The antibiotic could be insertedinto the conduit in biodegradable form or into a slow release pump, andwould be released from the anchor end during the night to combatperiodontal disease.

Another embodiment is medicine for gastrointestinal tract disease, anon-limiting example might be anti acid medication for acid reflux intothe esophagus. This could be released directly from the retractor endinto the pharynx. An additional embodiment would combine a sensor for pHand supply of the medication together, such that acidic pH could besensed and treated efficiently.

Another embodiment is for the treatment of pulmonary disease. Currently,aerosolized medicines for lung diseases such as asthma or bronchitis areinhaled through the mouth. This is less efficient then direct deliveryto the pharynx via the retractor side of the device, or to the tracheathrough catheters that pass from device to or through the larynx to thelungs. Medications preferably delivered by this method would include,without limitation, corticosteroids, bronchodilators, anti-inflammatory,mucolytic medications and antibiotics.

In another embodiment device could be releasing a medication thatdiffuses into the oral cavity or through the walls of the conduit intotongue tissue. U.S. Pat. No. 5,464,395 to Faxon describes a catheter fordelivering therapeutic and/or diagnostic agents to the tissuesurrounding a bodily passageway. An illustrative and non-limitingexample might be a medication that reduces fat in the tongue base suchas a mixture of phosphatidylcholine and sodium deoxycholate. Thesemedicines have been injected subcutaneously to causse localizeddissolution of fat (Rotunda, A M et al, (2004), Detergent effects ofsodium deoxycholate are a major feature of an injectablephosphatidylcholine formulation used for localized fat dissolution.Dermatol Surg 2004; 30:1001-1008). Therefore the volume of the tonguebase could be gradually decreased to improve OSAS. In an alternativeembodiment the drug could be a chemotherapeutic agent for the treatmentof cancer. As a further alternative embodiment the device would deliverradiation to a cancer of the soft tissue of the tongue, soft palate,pharynx or larynx. Representative examples of the prior art are U.S.Pat. No. 6,251,059 to Apple; U.S. Pat. No. 6,267,775 to Clerc describesa medical device for centering radioactive treatment sources in bodyvessels.

EXAMPLE 8 Sensors and Neuroprosthetics

Sensors could be incorporated into the device to sense levels of gasesor metabolites in the local blood flow around the device, which in turnreflect the systemic circulation. Alternatively sensors could detect theelectrocardiogram, blood pressure, blood flow, position of the patient,vibration, temperature, tissue pressure or other physiologicalparameters. A transmitter could be incorporated within the device totransmit this signal to receivers outside the body. As a furtherembodiment the remote computer system would analyze the signals and sendcontrolling signals back to the implanted device to control the releaseof drugs from the device, a neuroprosthetic device, or other medicaldevice.

Examples of prior art are U.S. Pat. No. 6,636,769 to Govani describingan implanted sensor and telemetric system. U.S. Pat. No. 6,558,321 toBurd describing a system whereby the monitored signal is sent bytelemetry to a remote computer which in turn sends signals back tocontrol an implanted medical device; U.S. Pat. No. 5,109,850 to Biancodescribes an implanted drug reservoir with a sensor that samples bloodand controls the delivery of medication; U.S. Pat. No. 6,764,446 toWolinsky describes an implant for surgical insertion in the mammalianbody to monitor pressure or other physiological parameters and/orperform therapeutic functions, has a pressure sensor, controller,acoustic transducers, and an energy storage device

A non-limiting example of this alternative a sensor in the devicemeasures blood glucose levels, and in turn controls the release ofappropriate amounts of insulin from a depot of this medication alsoincorporated into the device.

In another embodiment that treats OSAS the implant could haveelectrodes, battery power and stimulation electronics implanted tostimulate surrounding tissue. In one embodiment of the invention theimplant contains sensors for negative pressure at the retractor end.These sensor detect airway obstruction. These signals in turn triggerelectrical stimulation to the genioglossus muscle via surface electrodeson the exterior of the device in direct contact with the muscle. Thestimulation causes contraction of the genioglossus muscle and anteriordisplacement of the tongue thereby relieving the obstruction.

In an alternative embodiment a patient has Parkinson's disease and hasdifficulty initiating a swallow when eating. An embodiment of the deviceis implanted that in the centerline of the tongue from the frenulum tothe lower tongue base. The implant has a energy supply a receiver, andstimulation electronics. The retractor end of the device has electrodeson either side of a 1 cm flange in the valecullae. The patient has asmall control unit that can send a signal to the device and causeelectrical stimulation to excite sensory nerves in the valleculaethereby initiating a swallow.

EXAMPLE 9 Surgical Access

Surgical procedures on the pharynx, larynx, lungs and esophagus havenotably high morbidity. Although topologically these areas are outsidethe body the mouth and pharynx are a functional barrier to accessingthese areas. As the neck contains so many different important structuressurgical access almost invaribaly requires injuring normal structures.Moreover many surgical procedures, such as those for the treatment ofcancer, are designed to accomplish their aims in the short time periodthat the interior of the body is accessible under anesthesia. Thereforesurgical procedures are often more extensive they necessary. In contrastcancer that is located on the skin is often handled quite differently.The ready access to the area allows excision of minimum tissue, andrepeated followup as necessary. In the upper airway almost all cancerbegins on the surface. Therefore if access were easier some procedureson the pharynx and neighboring areas could be performed with lesscollatteral damage and shorter recovery times.

At present the technology for minimally invasive endoscopic surgery hasadvanced tremendously. Many procedures that once required wide incisionsand large exposure are now performed through small percutaneouspunctures using endoscopic and microsurgical equipment. The differencein morbidity and post operative recovery between the two methods aredramatic.

One alternative embodiment of this invention to provide conduits forsurgical access to the pharynx and neighboring structures. In oneembodiment the number, diameter and orientation of the conduits would beimplanted specifically for the disease to be treated so as to providemaximum ease in performing endoscopic surgery. In a further embodimentthese conduits could be accessed repeatedly over long periods of time toallow direct examination and continuing therapy.

As a non-limiting example a 65 year old male has a 2 cm ulcerated lesionof his pharyngeal wall. The lesion is biopsied and found to be squamouscell carcinoma. Medical and radiological examination suggest the lesionis localized to the pharyngeal wall and does not appear to have spreadbeyond the mucosa. After consultation with the patient on his treatmentoptions it is decided to remove the lesion with endoscopic methods. Twocollapsable conduits are implanted to access the lesion, the firstpasses through the centerline of the tongue from the frenulum to themidtongue base. The second passes through the skin of the undersurfaceof the jaw to enter at the base of the tongue 1 cm below the firstconduit. The patients first procedure is performed under generalanesthesia. Using a laser the lesion is vaporized via a rigid endoscopepassed through the mouth. However, after the initial procedure thepatient returns for followup examinations to the surgeons office everytwo weeks. Under minimal local anesthesia microsurgical endoscopes arepassed through each conduit. Each is equipped with 1 mm fiber opticcable that delivers hi intensity illumination and captures video images.The surgeon examines the lesion closely and biopsies any suspicioustissue. When indicated the surgeon injects chemotherapeutic agents intoand around the area biopsied. After six months the percutaneous conduitis removed and the patient is instructed to return monthly. After 1year, no recurrence is evident and the second conduit is removed.

LEGEND TO DRAWINGS

BA, Tongue base a, anchor, BD, Tongue body ab, airway ballon BL, Tongueblade c, collar Bo, Boundary between tongue and cc, collapsible conduit(cc) genioglossus C, Tongue curve d, diaphragm, F, Frenulum h, handleGG, Genioglossus muscle i, injection port, GT, Gastric tube n, needle,HP, Hypopharynyx p, open end of tube LR, Laryngeal soft tissue retractorpa, pressurized air NP, Nasopharynx r, retractor balloon, P, Hard palaterc, resealable cap PR, Pharyngeal wall retractor; s, shaft, PT,Pulmonary tube sc, surgical conduit SP, Soft palate st, suction tube SR,Soft palate retractor; t, tube, T, Tongue v, vacuum source VP,Velopharynx

1-18. (canceled) 19) A device for communication with at least one of thegastrointestinal tract and the respiratory system of a patient in needof said communication comprising: a) a trans-tongue member having anaperture; and b) a tube passing through said trans-tongue member adaptedfor communication between the exterior of said patient and a portion ofat least one of said patient's gastrointestinal tract and respiratorysystem. 20) A device for monitoring the health of a patient comprising:a) a trans-tongue member; and b) a sensor coupled to said trans-tonguemember. 21) The device of claim 20 in which said sensor comprises atleast one of a mechanical transducer and a chemical detector. 22) Thedevice of claim 20 in which said sensor measures at least one of acondition in a portion of the tissue near said sensor and a condition ina portion of the circulatory system. 23) The device of claim 20 in whichsaid device further comprises an electrode adapted to provide anelectrical stimulus. 24) The device of claim 20 further comprising atleast one member of the group consisting of a transmitter and areceiver. 25) A device for providing an electrical stimulus comprising:a) a trans-tongue member; and b) an electrode adapted to provide anelectrical stimulus. 26) A device for delivering a drug to a patient inneed of said drug comprising: a) an implantable member having anaperture; and b) a drug reservoir connected to said implantable memberand adapted to gradually release said drug. 27) The device of claim 26in which said implantable member comprises a bioabsorbable material. 28)The device of claim 19 in which said communication comprises fluidtransport. 29) The device of claim 19 in which said communicationcomprises an imaging device. 30) The device of claim 29 in which saidimaging device comprises a fiber optic. 31) The device of claim 19comprising an endoscopic surgical member. 32) A tissue retractor fortreatment of a breathing disorder, the tissue retractor comprising: a) ashaft sized for insertion into a soft tissue located in a patient's oralcavity or pharynx; b) a retractor member connected at or near a firstend of the shaft; and c) an anchor member connected at or near a secondend of the shaft, wherein at least one of the retractor member and theanchor member is configured to be positioned on an external surface ofthe soft tissue, and at least one of the shaft, the retractor member andthe anchor member interact to exert a pressure that prevents deformationof the external surface that brings the soft tissue toward another softtissue located in the patient's oral cavity or pharynx. 33) The tissueretractor of claim 32 wherein the pressure stiffens the soft tissue toprevent deformation of the external surface, the pressure is acounterforce pressure that prevents deformation of the external surface,the pressure is a counterforce pressure that creates an indentation inthe external surface, or at least one of the retractor member, theshaft, and the anchor member adjust to alter the pressure exerted on thesoft tissue. 34) The tissue retractor of claim 32 wherein the shaft isflexible. 35) The tissue retractor of claim 32 wherein the shaft isremovable. 36) The tissue retractor of claim 32 wherein at least one ofthe retractor member, the shaft, and the anchor member comprises aninflatable tube. 37) The tissue retractor of claim 32 wherein at leastone of the retractor member and the anchor member is disengagable fromthe shaft. 38) The tissue retractor of claim 32 wherein the shaftcomprises an internal passageway for adding a fluid. 39) The tissueretractor of claim 38 wherein the shaft comprises a regulator for saidfluid. 40) The tissue retractor of claim 32 further comprising aconnection to at least one of the patient's pharynx, the patient's oralcavity, the patient's tooth, a dental device, and a mount exterior tothe patient's mouth. 41) A method for treatment of a breathing disorder,the method comprising: a) inserting a shaft into a soft tissue locatedin a patient's oral cavity or pharynx; b) connecting a retractor memberat or near a first end of the shaft; and c) connecting an anchor memberat or near a second end of the shaft, wherein at least one of theretractor member and the anchor member is positioned on an externalsurface of the soft tissue and at least one of the shaft, the retractormember and the anchor member interact to exert a pressure that preventsdeformation of the external surface that brings the soft tissue towardanother soft tissue located in the patient's oral cavity or pharynx. 42)The method of claim 41 wherein the pressure is a counterforce pressurethat creates an indentation in the external surface, the pressurestiffens the soft tissue to prevent deformation of the external surface,or the pressure is a counterforce pressure that prevents deformation ofthe external surface. 43) The method of claim 41 further comprising thestep of: d) adjusting at least one of the retractor member, the shaft,and the anchor member to alter the pressure exerted on the soft tissue.44) The method of claim 41 wherein the anchor member is in communicationwith a muscle that is active during sleep. 45) The method of claim 41wherein the anchor member is connected to at least one of the patient'stooth, a dental device, and a mount exterior to the patient's oralcavity. 46) The method of claim 41 wherein at least a portion of atleast one of the shaft, the retractor member and the anchor member ispositioned in the patient's epiglottis. 47) The method of claim 41further comprising positioning the retractor member, the shaft, and theanchor on a needle and inserting the needle to a desired depth withinthe soft tissue. 48) A tissue retractor for treatment of at least one ofsnoring and sleep apnea, the tissue retractor comprising: a) a shaftsized for insertion into a patient's tongue; b) a retractor memberconnected at or near a first end of the shaft; and c) an anchor memberconnected at or near a second end of the shaft, wherein at least one ofthe retractor member and the anchor member is configured to bepositioned on an external surface of the tongue, and at least one of theshaft, the retractor member and the anchor member interact to exert apressure that prevents the external surface from falling toward a softtissue located in the patient's oral cavity or pharynx. 49) The tissueretractor of claim 48 wherein the shaft is sized for insertion throughthe patient's tongue. 50) The tissue retractor of claim 48 wherein thepressure is a counterforce pressure that prevents deformation of theexternal surface, the pressure is a counterforce pressure that createsan indentation in the external surface, or the retractor member, theshaft, and the anchor member adjust to alter the counterforce pressureexerted on the tongue. 51) The tissue retractor of claim 48 wherein thetissue retractor is formed from one or more biocompatible materials. 52)The tissue retractor of claim 48 wherein the shaft is flexible. 53) Thetissue retractor of claim 48 wherein the shaft is removable. 54) Thetissue retractor of claim 48 wherein at least one of the retractormember, the shaft, and the anchor member comprises an inflatable tube,or the shaft comprises an internal passageway for adding a fluid. 55)The tissue retractor of claim 48 wherein the external surface is thecenterline of the tongue curve. 56) The tissue retractor of claim 48wherein at least one of the retractor member and the anchor member isdisengagable from the shaft. 57) The tissue retractor of claim 48further comprising a connection to at least one of the patient'spharynx, the patient's oral cavity, the patient's tooth, a dentaldevice, and a mount exterior to the patient's mouth. 58) A method fortreatment of at least one of snoring and sleep apnea, the methodcomprising: a) inserting a shaft into a patient's tongue; b) connectinga retractor member at or near a first end of the shaft; and c)connecting an anchor member at or near a second end of the shaft,wherein at least one of the retractor member and the anchor member ispositioned on an external surface of the patient's tongue, and at leastone of the shaft, the retractor member and the anchor member interact toexert a counterforce pressure that prevents the external surface fromfalling toward a soft tissue located in the patient's oral cavity orpharynx. 59) The method of claim 58 wherein the counterforce pressurecreates an indentation in the external surface. 60) The method of claim58 further comprising the step of: d) adjusting at least one of theretractor member, the shaft, and the anchor member to alter thecounterforce pressure exerted on the patient's tongue. 61) The method ofclaim 58 wherein the first end of the shaft is connected at or near thebase of the tongue and the second end of the shaft is connected at ornear the frenulum. 62) The method of claim 58 wherein the anchor memberis in communication with a muscle that is active during sleep, or theanchor member is connected to at least one of the patient's tooth, adental device, and a mount exterior to the patient's oral cavity. 63)The method of claim 58 wherein at least a portion of at least one of theshaft, the retractor member and the anchor member is positioned in thepatient's epiglottis, both the retractor member and the anchor memberare positioned adjacent the superior surface of the patient's tongue, orthe retractor member is on one side of the frenulum, the shaft isbeneath the tongue curve, and the anchor member is on the other side ofthe frenulum. 64) The method of claim 58 further comprising positioningthe retractor member, the shaft, and the anchor on a needle, insertingthe needle to a desired depth within the patient's tongue, and removingthe needle. 65) The method of claim 58 wherein step a) furthercomprises: a1) positioning the shaft in a needle bore; a2) inserting theneedle bore at or near the junction of the frenulum and the tongue bladewith a tip of the needle bore oriented toward the tongue curve; a3)advancing the needle bore through the tongue; and a4) removing theneedle bore while maintaining the shaft in the patient's tongue. 66) Atissue retractor for treatment of at least one of snoring and sleepapnea, the tissue retractor comprising: a) a shaft configured forinsertion into a patient's tongue; b) a retractor member connected at ornear a first end of the shaft, and c) an anchor member connected at ornear a second end of the shaft, wherein at least one of the retractormember and the anchor member is configured to be positioned on anexternal surface of the tongue, and at least one of the shaft, theretractor member and the anchor member prevents at least a portion ofthe tongue from collapsing toward a soft tissue located in the patient'soral cavity or pharynx. 67) The tissue retractor of claim 66 wherein theshaft is removable. 68) A tissue retractor for treatment of at least oneof snoring and sleep apnea, the tissue retractor comprising: a) a shaftsized for removable insertion through a patient's tongue, the shafthaving a first end connected at or near the base of the tongue and asecond end connected at or near the frenulum; b) a retractor memberconnected at or near the first end; and c) an anchor member connected ator near the second end, wherein the retractor member is configured to bepositioned on an external surface of the tongue, and the shaft, theretractor member and the anchor member interact to exert a counterforcepressure that prevents deformation of the external surface in adirection toward a soft tissue located in the patient's oral cavity orpharynx. 69) The tissue retractor of claim 68 wherein the counterforcepressure prevents the external surface from falling toward the softtissue. 70) A method for treatment of at least one of snoring and sleepapnea, the method comprising: a) inserting a shaft into a patient'stongue, the first end of the shaft is connected at or near the base ofthe tongue, and the second end of the shaft is connected at or near thefrenulum; b) positioning a retractor member at or near the first endadjacent the base of the tongue; and c) positioning an anchor member ator near the second end adjacent the frenulum, wherein the retractormember is positioned on an external surface of the patient's tongue, andthe shaft, the retractor member and the anchor member interact to exerta counterforce pressure that prevents deformation of the externalsurface in a direction toward a soft tissue located in the patient'soral cavity or pharynx. 71) The method of claim 70 wherein thecounterforce pressure prevents the external surface from falling towardthe soft tissue. 72) A method for treatment of a breathing disorder, themethod comprising: a) inserting a shaft into a soft tissue located in apatient's oral cavity or pharynx; b) connecting a retractor member at ornear a first end of the shaft; and c) connecting an anchor member at ornear a second end of the shaft, wherein each of the shaft, the retractormember, and the anchor member contact solely soft tissue, and the shaft,the retractor member, and the anchor member interact to exert a pressurethat prevents deformation of at least a portion of the soft tissue toprevent obstruction of the patient's airway. 73) The method of claim 72wherein the soft tissue is the patient's tongue, the retractor membercontacts soft tissue in the patient's tongue that retracts at least aportion of the patient's tongue curve, and the anchor member isimplanted in the genioglossus muscle. 74) A device for treatment of abreathing disorder, the device having a first end, a second end, and ashaft disposed therebetween, the shaft is adapted to be disposed througha soft tissue located in the patient's oral cavity or pharynx, with atleast one of the first end and the second end being positioned on anexternal surface of the soft tissue with each of the first end and thesecond end contacting solely soft tissue, and with at least one of thefirst end, the second end, and the shaft interacting to exert a pressurethat prevents deformation of at least a portion of the soft tissue toprevent obstruction in the patient's airway. 75) The device of claim 74wherein both the first and the second end are configured to bepositioned on an external surface of the soft tissue.